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00:07 Welcome to the Landos Biopharma Corporate Update Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Becky Mosig, Director of Administration and Operations at Landos. Becky, please go ahead.
00:46 Good morning everyone. Thank you for joining us today. With me on the call today are Chris Garabedian, Landos’ newly appointed Chairman of the Board; Tim Mayleben, Interim President and CEO; and Patricia Bitar, Interim CFO. We will take your questions after comments by Chris and Tim.
01:05 Please be aware that all statements in our prepared remarks and in response to your questions other than those of historical facts, including statements regarding our future results of operations and financial condition, business strategy and plans, and objectives of management of future operations are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of nineteen ninety five.
01:27 All such forward-looking statements are inherently subject to risks, uncertainties, and assumptions and are not guarantees of performance and are expressly qualified in their entirety by cautionary statements. The forward-looking statements made are as of today’s date and we under take no obligation to update them to reflective ends or circumstances after today or to reflect new information, actual results, revise expectations or the occurrence of unanticipated events, except for as required by law.
01:55 We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statement and you should not place undue reliance upon our forward-looking statements. For more details please refer to our earnings press release and to the risk factors and our other SEC filings, particularly the risk factors in our annual report on Form ten K and subsequent quarterly report on Form ten Q.
02:19 With that, I’ll turn it over to Chris.
02:23 Good morning everyone. Thank you for joining us. Today, we’ll be providing a corporate update and discussing our renewed focus on advancing our promising clinical stage programs to ensure we have the optimal advanced development strategy to ensure a successful path to commercialization for our products.
02:42 We will share our vision for the company one that will see Landos sharpen its focus and prioritize the most important product development activity to maximize both near term and long term value for patients and our shareholders. As many of you know, we issued a press release last Monday announcing a leadership transition.
03:02 Josep Bassaganya-Riera, founder of Landos, stepped down as Chairman and CEO and has agreed to serve as an advisor to the company. I have personally been actively involved with Landos since our founding. And I'm honored to be serving as Chairman. Tim Mayleben, our fellow board member and highly experienced industry executive and former public company biotech CEO has agreed to lead the company as Interim President and CEO during this important time, while the board conducts its search for Landos’ next leader as permanent CEO. Additionally, Patricia Bitar, who is also on our call today was appointed Interim CFO.
03:43 Before I continue, I'd like to thank Josep for his leadership and vision in founding and creating a truly innovative company with a science driven, entrepreneurial culture that has set the company up for a promising future. It was his vision for the Landos scientific platform that helped create an incredibly robust pipeline with three clinical stage product candidates and four additional preclinical assets across three novel mechanisms of action, all with unique drug-like characteristics.
04:15 For the potential treatment of autoimmune and other immune mediated inflammatory diseases, we appreciate his continued support as an advisor and shareholder. With seven product candidates in the pipeline across three novel mechanisms and numerous, potential disease indications, Josep and the Board agreed that it was the right time to transition to our next phase of leadership and to identify a CEO with experience managing multiple clinical programs, a promising research platform, and domain expertise in the disease categories in which Landos competes.
04:50 As the Board executes this search, we're fortunate to have a leader of Tim’s caliber at the helm. Tim is a seasoned veteran in the industry and since joining our Board, he's played a valuable role in helping Landos navigate the market as a publicly traded company. Under Tim's agreement to assume the interim leadership position, we believe Landos will continue to be productive in advancing their research programs and be better prepared to position the company for future success while we search for the best permanent CEO for the company.
05:21 With that, I'd like to provide a brief overview of our thoughts and perspective on how far Landos has come and how we plan to best position the company for success in the coming months and years. Then I'll turn it over to Tim to provide additional details on our research activities and additional plans to help refocus and reprioritize the company's current efforts.
05:42 Over the last four years, Landos has transformed itself from a small organization with a single preclinical product candidate now known as Omilancor into a clinical stage company with one of the most promising portfolios in the immune mediated inflammatory disease field.
06:00 During that time, we've achieved several important milestones, including having completed a Phase two clinical study of Omilancor in ulcerative colitis with encouraging results, preclinical testing and IND and completion of a Phase one safety dosing PK study of NX-13, in healthy volunteers, enabling Landos to enter a Phase 1b study in ulcerative colitis patients that is currently enrolling, and preclinical testing in an IND for LABP-104 enabling Landos to enter Phase one safety dosing PK trials in healthy volunteers that is also currently enrolling.
06:39 And finally, preclinical testing on four additional product candidates, including LABP-69, which represents the third distinct mechanism of action for the Landos portfolio. As you can see, Landos has established itself as an incredible productive research engine with a pipeline of numerous novel product candidates targeting unmet needs in these new mediated inflammatory disease areas.
07:06 We are confident Landos is well positioned to drive success in value for many years to come. As a result of this productive research engine that has produced such an abundant portfolio, Landos has had an important inflection point, which requires an intense focus on the optimal advanced development strategy. This includes thoughtful consideration of our future clinical strategy and trial designs for each program. This includes determining the appropriate enrich patient populations for each study and indication.
07:39 These are defined by the careful consideration of inclusion exclusion criteria. Good clinical trial design also includes determining the optimal clinical endpoint, the powering assumption and the regulatory strategy that will drive the most successful and expedited path to commercialization.
07:58 To this end, I'm pleased to announce today that we are refocusing and re-prioritizing Landos’ research and development activity and providing revised guidance for the development of our three clinical stage products. While the company has communicated many possibilities for additional preclinical products and additional disease indications in which INDs can be pursued, we will be prioritizing the product portfolio and [Technical Difficulty] the focus of the company on a relatively narrow set of indications, including Omilancor, which targets the LANCL2 pathway for the gut-restricted treatment of patients with ulcerative colitis, Crohn's disease and Eosinophilic Esophagitis or EoE.
08:40 NX-13, which targets the NLXR1 pathway for the gut-restricted treatment of patients also with ulcerative colitis and Crohn’s disease, which also has the promise as a complementary and/or common [material] [ph] approach alongside or Omilancor.
08:57 And finally, LABP-104, our third product in the clinic, which also targets the LANCL2 pathway, but with more diffuse systemic exposure and activity for the treatment of patients with Lupus and Rheumatoid Arthritis. We are confident that enhancing our focus on advancing these three highly promising novel assets with the right development strategy program design and optimized clinical trials will drive the greatest value for our company and its shareholders.
09:27 Importantly, I want to emphasize that our mission at Landos remains the same. We remain committed as ever to discovering and developing novel oral small molecule therapeutics for patients with indications in immune metabolic and immune inflammatory disease space.
09:46 Now, I'd like to turn the call over to Tim to provide a further update on Landos’ near term clinical plan and other research and corporate activity. Tim?
09:59 Thank you, Chris. First, like Chris, I want to acknowledge what a great honor it is for me to serve in my case as Interim President and CEO of Landos. To tell you a little bit about myself, I have more than two decades of leadership experience in the development and approval of innovative therapies.
10:17 I have long viewed Landos as a particularly innovative company in our industry and since joining the board in May I’ve gained an even deeper appreciation for the important role we have in developing first in class oral therapeutics that will address the unmet needs of patients with immune mediated inflammatory diseases.
10:40 Over the last few days, I've been on-site in Blacksburg and have witnessed firsthand the passion, the dedication of our talented team. It's an exciting time at Landos and we're looking forward to continuing our momentum as we build on the strong foundation of the clinical stage programs.
10:59 So, let me talk now, more specifically about each of the clinical stage programs that were focused on advancing. First, for Omilancor in ulcerative colitis, we plan to leverage the learnings from the initial Phase two study, including a number of compelling post hoc analyses from our research team to design and run a robust Phase 2b study.
11:24 While results from the Phase two study and mild to moderate you see, patients were encouraging. We firmly believe that the right drug development decision and the right clinical strategy for Omilancor for the long term in ulcerative colitis will require building on this data in Phase 2b to gain additional perspectives on the optimal dose, the most enriched patient population, the powering assumptions, and other considerations to inform a pivotal Phase three program and support regulatory approvals.
11:58 We're going to take a very close look at these variables and we'll be working with our outside consultants and advisors, including our clinical advisory Board in the coming weeks to complete those plans. And we expect to be in a position to communicate updates early next year.
12:16 Next, let me speak to the four active clinical studies that we have ongoing, a Phase two study of Omilancor in Crohn's disease patients, a forty patient single site mechanistic study of Omilancor in Crohn's disease patients led by prominent investigators at Mount Sinai and co-sponsored by NIH. A Phase 1b dose ranging study of NX-13 in ulcerative colitis patients and a Phase one safety dosing PK study of LABP-104 in healthy volunteers.
12:52 So first, I want to say we're very pleased with the progress in each of these studies. The studies continue to enroll subjects and are proceeding as planned. That said, going forward, we won't continue the previous practice of guiding on the timing for top line clinical study results.
13:15 We're also actively evaluating the sample size of the Phase two study of Omilancor and Crohn's disease and the Phase 1b study of NX-13 and ulcerative colitis to ensure Landos optimizes the powering of our data for these studies.
13:33 Next, I'd like to speak about the research efforts at Landos, our promising, preclinical pipeline and the opportunity for expanded indications across the entire product portfolio. As many of you know, our AI driven proprietary research platform also known as LANCE, has successfully identified new multimodal pathways at the intersection of immunity and metabolism resulting in a robust pipeline of IND candidates with unique product profiles.
14:05 As Chris mentioned, given our renewed focus on the optimal development strategy for our clinical stage product candidates, we believe this is a good opportunity to conduct a strategic review of the preclinical programs. And this is going to focus on the optimal prioritization and sequence of these additional preclinical products and their respective clinical applications.
14:31 And again, going forward, we will not be providing you detailed guidance or updates on each of our preclinical programs. Given the focus on our plan to develop our clinical stage product candidates. We're also withdrawing Landos’ previous guidance for communicating additional IND filings. And this includes additional indications for the product candidates currently in clinical development, as well as our preclinical portfolio.
15:07 Turning now to partnerships. We remain very excited about our development and commercial partnership with LianBio for Omilancor and NX-13 in China and other Asian markets. The Landos and LianBio teams are already collaborating on the development of these product candidates and we look forward to our future success together.
15:31 Now, before we open the call to your questions, I would emphasize that this is an important time for Landos. I look forward to collaborating with the Landos team to advance our high impact clinical stage product candidates and the entire board and Chris and I are focused on positioning Landos for success.
15:51 We believe and we're confident the future is bright for Landos, and there are significant opportunities for partnering and commercialization ahead as we enter our next phase of growth. We have a tremendous amount of confidence in our platform and look forward to updating you on our efforts.
16:09 So with that, we're happy to take any questions you may have. Andrea, if you would poll for questions. Thank you.
16:18 [Operator Instructions] And our first question will come from Chris Howerton of Jefferies. Please go ahead.
16:52 Great. Thank you so much for taking the questions and obviously pretty exciting and shall I say tumultuous time for Landos, but I think positive things ahead. So, I guess, two questions from me. One would be, how are you thinking about the current kind of cash balance in capital deployment towards clinical programs versus prioritization of other things and business development, and I guess things like that that you can say at this point? And then the second question was around ulcerative colitis with respect to the severity of the disease, what is the right kind of patient population or what information did you see in the Omilancor prior clinical results that encourage you to continue development there in ulcerative sort of colitis in maybe a different patient population? Thank you.
17:49 Yeah, thanks. Chris, I think Chris, will take your second question first, and then I'll come back and answer your first question.
18:00 Yes. So, the Phase two data we saw in ulcerative colitis, as we looked at that, we were very encouraged and it was a different patient population that has typically studied in Phase two studies and that we included mild patients. And when we did our subset analysis, the mild patient dataset was harder to interpret.
18:23 Those with active disease, we think had some benefit, but the moderate population, which is where most of the competitive products have focused their studies. We were right up there with kind of best in class drugs. So, we felt that that was and we're talking about placebo adjusted remission rates. So, we were very encouraged by that. We didn't have as many biologic exposed patients that we were hoping for, but those patients responded well also.
18:57 So, we think that the encouragement from the moderate patient population, the encouragement from the small group of patients that were previously exposed to biologics and still did well on Omilancor gives us the confidence that we have an active drug that can produce really good efficacy results and we really felt that we wanted to understand the performance of the drug in these populations through additional clinical studies before locking into a larger Phase three study.
19:29 As you know, powering assumptions, sample size calculations are driven on what data you have from previous studies and we feel that we will be in the best position to accelerate development in this by gathering some additional data in some of these populations, the moderate, the biologic exposed. We haven't fixed on any specific study designs yet, but that's what Tim and I along with outside advisors are going to be focusing in on. And on the balance sheet, I'll kick that over to Tim.
19:58 Yeah. Thank you. Chris. And Chris, maybe I'll start out by, I know we spoke briefly last week. Just saying we're in day seven in terms of this leadership transition, but having said that, what I think we can say is, we've got over one hundred million dollars in cash. I think we indicated that that carries us through the next two years.
20:25 And again why we don't have a, as you’ve heard us say, we don't have a precise design for a Phase 2b study, given our experience in Phase two, we have a pretty good idea of what these studies cost on a per patient basis. So, we feel like the cash that we have is going to carry us through that next couple of years one.
20:48 And two, that given this refocus and prioritization on these current clinical stage assets, and that's where you're going to see us deploying the money. I think as that rolls out over the next couple of quarters, we can certainly provide more detail, but I think that gives you a general idea of where we see the cash going in the future.
21:12 Yeah. No, that's really – that's helpful. I appreciate that. And maybe if I could sneak in one more, was just the idea of in terms of the Phase 2b or ulcerative colitis patient population, I think one of the questions that I always had from an external perspective was, is dose, was dosed explored fully? So, I guess if you had any comments about evaluating additional dosing regimens or concentrations? Thank you.
21:41 Yeah. I mean, look, I think anybody who's actually looked at the data set understands we did look at zero point five gram and a gram. The active ingredient was slightly less than that four forty and eight eighty has been communicated by the company more recently as the dose groups. So that was driven based on the multiple pig models that we did and where we were seeing a dose plateau and where we felt that we saw a maximum dose effect. The pig local activity translates pretty well based on historical models to the human population.
22:22 So that's how we were driving the dose. However, we did not really see a clear dose response. And so part of what we are wanting to determine by looking at additional patients is try to tease out right? If the lower dose is truly a dose plateau or if some patients may benefit from the higher dose of a gram. It's not off the table to even look at higher doses. Our safety margins were quite significant in both animal studies and the healthy volunteer studies.
22:56 So, we are going to look very deeply at this, we are going to be confirming and consulting with external advisors, as well as other industry, consultants who have experience in these disease areas and also really looking more deeply in mining that data to tease out if there's other findings, but I think right now we're not ready to declare what the optimal dose is moving forward.
23:21 And I think that we're encouraged by the fact that we don't think we are near dose limiting toxicities and we think we have a healthy margin above that. So, stay tuned, we don't have details to share at this point, but figuring out the right dose is definitely part of our plans ahead.
23:40 Okay. All right. Well, I really appreciate you guys taking all the time to answer my questions and indulging me. So thanks again. Bye-bye.
23:47 Thank you, Chris.
23:50 The next question comes from Jessica Fye of J.P. Morgan. Please go ahead.
23:56 Hey guys. Good morning. Thanks for taking my questions. Completely agree on the updated strategy on Omilancor to do some more Phase 2b work here. So, on that note, can you talk even in broad strokes about the trial design you're envisioning or considering for Phase 2b? Should we interpret the comments you made a few minutes ago about the data in mild patients being difficult to interpret suggesting that we should not necessarily expect a comparable patient population enrolled in Phase 2b as what you had previously outlined for Phase three? And I guess, I'm curious as it relates to powering that study to the extent it may enroll a patient population that is different from the moderate to severe patients we see studied in many other UC trials, how you just even for powering that study, kind of come to a view on what the placebo arm would be expected to do? Thank you.
25:00 Yes, Jessica great questions. So first, one of the adjustments that we had already made even when it was, Josep was leading the design on the Phase three was removing mild patients without active disease.
25:15 I think one of the questions we have is, should we still include mild patients with active disease or should we stick with the more moderate and maybe moving into the [indiscernible] as traditional with the study, this is always a trade off with how many patients get biologics earlier before they get it severe, how many we want to include that were previously exposed and whether or not the mild with active diseases is an appropriate population.
25:43 Now, we haven't determined that. I think we are pretty confident that we're not going to include mild patients without active disease. And we want to make sure that we have sufficient numbers of moderate patients because we think if we reproduce the dataset from Phase two and the moderate and powered it on the moderate alone that we could have had more robust findings, meaning statistically significant.
26:09 So, we will be looking at that very closely. One thing that we haven't fixed in on is whether we do instead of a single study in repeating a study in moderate to severe patients with or without biologics is, are we better suited to do two studies? One that might be more moderate biologic naïve, maybe mild with active and moderate, may be moderate – you know there aren't that many severe disease in the more developed countries, right and systems that haven't been exposed to biologics, but we could consider a separate study that just looks at those that were biologic exposed.
26:49 I'm just sharing kind of the early thoughts and thinking around this. This is why we have an advisory meeting coming out. We have other consultants we're engaging, and so this is – the key question you're asking is what we want to do is determine what are the right assumption? How many patients do we need to enroll? What's the best way to provide the most robust signal so that everybody understands that when we do design a Phase three study that we understand much more clearly, what is something should go into that, how we power that and how to ensure that we have a pivotal trial that meets its statistically significant endpoint? So, hopefully that answers the key question.
27:31 Yeah, that's great. And then just shifting to the slightly earlier studies, whether it was phase two for Omilancor in Crohn’s or the Phase 1b for NX-13, can you just remind us what the target enrollment had been for each of those studies and maybe help us think about where it could go?
27:53 Yes. I don't remember exactly. I don't know, Tim, I want to say, the Crohn's study we had eighty patients treated as my understanding or it may have been forty versus forty. This was not powered for statistical significance. Even the company acknowledge that. And so part of the reason for re-guiding on the Crohn’s study is, we want to understand well, what does the timeline and sample size look like if we did power it for statistical significance, right?
28:28 Look, we don't dismiss the idea of exploratory clinical trials being able to draw conclusions off of non-statistical data, but we wanted to make sure that if it was possible to do a larger study to drive toward a statistically significant benefit Crohn's that we would do that. I can't tell you right now what that sizing looks like, how easy that would be to achieve based on enrollment and timelines, but that is definitely something that's on the table.
29:01 As it goes for NX-13 and also Crohn’s, this is a dose ranging study, this is, I guess less critical to drive for clinical outcomes, right, powering, it was not intended for that nor do we think that it's appropriate to try to drive that toward a clinical outcome study, but we do want to look at that study as well to make sure we're going to get reliable trustworthy information with the current sampling that exists in that and we'll relook at that as well, and that's why we've also remove the guidance of the top line data as we determine, right, the appropriate enrollment and sample sizes for the study. Tim, did you want to add anything to that?
29:43 Yeah. Jess, the only thing I was going to say is, we'll follow-up with you afterwards and just, because I think Chris nor I have the numbers off the top of our head, but easy for us to grab afterwards and send to you.
29:58 Great. Thank you.
30:03 The next question comes from Thomas Smith of SVB Leerink. Please go ahead.
30:10 Hey guys. Good morning. Thanks for taking the questions. Just, so we're in this pretty important transition point here. Maybe for Chris and Tim, can you just talk to your level of confidence in some of the underpinning science and translational data that we've seen to date?
30:27 Yeah. I have to say, we have tremendous confidence in this research platform in the data that drove the selection of the lead compounds. I have say, I've been involved with this company from inception. We were the original investors as part of the perspective funds. As Xontogeny Collaborated, Perceptive Xontogeny Ventures Fund and Perceptive Hedge Fund investing in this. And the thing that was most compelling was the great work that was done in the lead compoundable Omilancor.
31:07 When we first looked at this and before it was spun out into Landos, there were multiple rodent models that looked very good, showed good concordance on the inflammatory biomarkers down regulating the pro inflammatory cytokines, up regularly the anti-inflammatory cytokines, and they were different induction models of inflammation.
31:31 We went further with pig data because we wanted to ensure that we really understood the dose activity relationship with a gut-restricted drug. We think a lot of drugs that rushed into the clinic on rodent data alone didn't really understand what was happening in the Gastrointestinal Tract.
31:54 And we got good concordance and good understanding of the right dose where it was localizing in the Gastrointestinal Tract, how well it was penetrating the [indiscernible] lining, where we were seeing a dose plateau, how persistent it was to give us confidence in the once daily dosing?
32:12 And so, we think that the selection of Omilancor and how robust the dataset has been to date, right, proves that platform and we're seeing that similarly with the second drug that's been brought into the clinic, NX-13 with some of the signals and biomarkers we saw even in a healthy volunteer study.
32:34 And then a third pathway was identified, which is in preclinical testing. And so, we have tremendous confidence in the research engine, the pipeline, the promise of the future. In some ways, Thomas, we were almost more successful sooner than we anticipated and we felt that, okay, in order for us to get this right, we need to focus on the products we have in the clinic, let's make sure we get that right, because that will prove research platform.
33:06 That will prove these pathways. That will prove that the LANCE platform really understands how to drive the best drugs and by the way, this is not new to the industry. You're seeing a lot of good AI machine learning applied to understanding how to find the optimized product candidates, but these are proving out in both preclinical and clinical testing.
33:28 So, in no way do we waiver it all from the strength of the research platform in the future of these products.
33:38 Understood. Okay. Yeah, that's helpful, Chris. Thanks for the color there. And then just on the Omilancor Phase 2b in ulcerative colitis in the Phase two and Chron’s, understand it's early days here and still a lot of moving parts. I guess just at a high level, and understanding a lot still to be refined, but do you sense at this point, how you're thinking about the timing for potential next clinical data points here?
34:08 Yes, I think – Tim do you want to cover that one?
34:11 Yes. So, I think Tom it is, as you said, it's still early. While Chris has been around the company for, well since its founding, I'm day seven here and I think one of the things we did in the press release, another thing we did in the prepared comments is, I think to go out of our way to say look, there's been a lot of guidance out there from the company historically on really granular things and I think as Chris said too, we've had tremendous success as a company in the early stage of discovery work, this incredibly strong foundation that we have with the LANCE AI platform, but the most important thing and again paradoxically, the most important thing we need to focus on is clinical strategy for these incredibly valuable assets in this immune mediated inflammatory disease space.
35:25 So, that's our focus. I would ask you and others for just a little bit of forbearance at least in the short term here, while we get our legs under us and make sure that when we're coming back to you, we're coming back to you with really rational thoughts on design on endpoints and on timing as well. Chris, anything that you wanted to add?
35:48 Yes. The only thing I would add is that, aside from the currently enrolling studies in patients, we have not revised guidance on LABP-104’s Phase one. We've shown historically that we can execute on Phase 1 studies, the single ascending, dose multiple ascending dose studies. So, we do expect that was guided on second quarter data. We are still retaining guidance on that study, but yes the other ones we want to make sure we have the right sampling, and we will be communicating any revised timelines and any adjustments to those two studies, as soon as we lock that down and we can't say exactly when that timing would occur.
36:31 Got it. Okay. Great. Thanks guys. Yeah. Appreciate the updates and the color.
36:36 Great. Thanks Thomas.
36:37 Thanks. Thanks, Tom.
36:39 The next question comes from Steve Seedhouse of Raymond James. Please go ahead.
36:45 Hey yes. Hi, this is Tim [indiscernible] on for Steve Seedhouse. So, another question on Phase 2b you see study. So, I think the original positioning was to be pre-biologic in sort of mild moderate patients, the white space between generic treatments and biologics, so are you saying now the highest unmet need is the moderate in post-biologics setting? And then maybe, can you also talk about the target effect side that will allow you to move forward into Phase three?
37:16 Yeah. So, this question has been of interest for Landos for a couple of years now. And I think that we pursued the mild to moderate for Omilancor initially because it was clear there were not many companies working in that space. And even advice from clinical advisers, right, key opinion leaders, right? They were longing for a drug that works in that space pre-biologics. And secondarily, it's easier to enroll those patients that have not been exposed, right? So, it was a way to get earlier data.
38:03 However, we also recognized that to really compete in this area, you need to prove your utility in the more advancing patients and that's moderate and increasingly more patients who are exposed to biologics were not well controlled. And so, I wouldn't say it's shift in strategy in any way, but we want to better understand it fact we included those exposed to biologics in the Phase two. And we had plans to include a minimum number, a much higher number percentage wise in what was described as the Phase three study previously.
38:41 So, we are definitely interested based on the signal and a small number of patients in the Phase two Omilancor UC see study to pursue that. I think the broader question that we have is, we have two drugs that are both gut-restricted going after ulcerative colitis and Crohn's and what is the optimal development strategy when you have two drugs, right?
39:06 It could be that we position one more favorably depending on the course of disease and stage of disease. It could be that they are complementary. It could be that there's some combinatorial strategies that we can pursue.
39:20 Right now, the goal is to clearly demonstrate these unique drugs activity as broad a population, meaning we need to understand how it works and moderate. We need to understand how works with biologic expo, and whether we pursue that mild active disease patient?
39:41 I think that's something we're going to be looking very closely at, but I don't know that we've been that emphatic or I was not aware that there was any communication saying that we would not pursue biologic exposed because that's always been part of the broader strategy.
39:58 Okay. Thank you for that. And then maybe for your Phase 2b study, you see, you have a relatively broad guidance for when you will be initiating the study in twenty twenty two. Can you just talk about some of the factors there? What may push this into the second half?
40:17 Well, I don't know if you're speaking of data readout is really hard to guide because we don't know what the sample sizes is and we have to calculate enrollment. I think if you're saying when we will initiate the next new study, yes. I think look; we're working closely. We're meeting with, advisors and consulting before the end of the year.
40:38 We're starting to dig in as Tim said, it is day seven, and so, we're excited to get deeper in our understanding of the datasets of being able to apply what Tim and I have both done with seeking the right outside advice from the experts, people who were involved in other clinical trials across the industry in this space, looking more deeply at the literature and what we've learned from other drugs who’ve failed and those who have succeeded in these patient population.
41:11 So, I think we hope to have a good idea of that as we move into the first part of next year, but we're not ready to say, you'll know when we are ready to communicate that via a press release and any corporate update and we don't want to continue right the habit of trying to forward project activities before we have that lockdown. But Tim, do you want to add to that?
41:43 No, I think you covered it well. Chris. Thank you.
41:48 Okay. Thank you. And then a final question just in Crohn’s business, just to clarify, you have a company sponsored phase two study. And then there is also the Icahn School of Medicine Phase two study, and just to clarify, are those studies both enrolling right now? And then to what extent is the Icahn study, a gate keeping factor to, you know initiating a Phase three program?
42:14 Yes, this is Tim. Thanks for that question. So, both studies are indeed enrolling and have enrolled patients already. I don't think we view the phase two single site study with Mount Sinai as gating to a pivotal Phase three program. It will certainly inform our insights into how Omilancor works in Crohn's disease, in Crohn's disease patients, obviously, how it compares to a biologic as well, but there's a lot of really interesting mechanistic work and testing that is going to be done that is going to yield, I think a great benefit to obviously – to be determined as we move along, but yes, I don't see that is gating.
43:19 Okay. Thank you very much for the updates.
43:22 Thank you.
43:23 Thanks.
43:25 The next question comes from Prakhar Agrawal of Jones Trading. Please go ahead.
43:32 Hi. Thanks for taking my question. Firstly, will you wait for the permanent leadership to come in before finalizing the trial design protocol and some of these changes or some steps such as optimizing the powering could be started sooner? And I have some follow-ups. Thanks.
43:50 Yeah. This is where I'll just add. It's nice that both Tim and I have a lot of experience leading companies, making these decisions as former public company CEOs. I think we will collect along with our fellow board members determine if we are ready to move forward and really that has more to do with, we want to find the right CEO, and we don't know how long that's going to take and we're not going to arbitrarily hold back the program right moving forward.
44:27 So, we will apply our best judgment and experience in working with advisors, companies, I mean, employees within the company, external key opinion leaders doing other competitive landscaping research and we obviously have regulatory biostats, you know people we work with in and out of the company. And so, that's how we plan to do it and we're not arbitrarily saying, we cannot lock anything down until CEO.
44:56 Obviously, our best hope is that we can find that CEO soon and they can be part of that process and development, but Tim, you should add to that.
45:08 Yes. I would just echo what Chris said, I think, we feel comfortable. First of all with having made the strategic decisions that we announced today. Again, just given our experience and obviously other members of the board as well, but secondly, I think drug development is waiting here, patients are waiting, and I think with Chris' background, with the company and with the set of advisors that we have around the company, we feel very confident in our ability to design and implement the appropriate Phase 2b program here Prakhar.
45:53 Got it. Thank you. And secondly, on Crohn’s, the company had previously guided on testing both Omilancor and NX-13, but I don't see any commentary on NX-13 in Crohn’s in the press release. So, just wondering if you think it makes sense to still plan to explore both [these assets] [ph] and Crohn’s. Thanks for fitting in my questions.
46:13 Yes. I think right now we're following the same path right now as Omilancor, yes, in terms of looking at UC first. Again, I think we will decide that and determine that. We still have highlighted Crohn’s, but look, there's a lot of programs that we've highlighted, right? So, we've got seven different clinical programs that we're saying is the top priority. We know that the company had previously communicated many other INDs that were planned, right, with other new indications, new products.
46:45 So, I think that right now, we have a healthy balance sheet. We can generate a lot of compelling data and that we will determine what the right timing and interest in that Crohn's development program is as we start to uncover more data for both Omilancor and BX-13 ulcerative colitis.
47:14 Okay. Thank you, Prakhar. Thanks to everyone else as well. Appreciate all of you joining the call today. And again, hopefully you've heard from us today, we're refocusing, we’re re-prioritizing things, a lot of confidence in particular the clinical stage assets and our goal here is to communicate all of you the confidence that we have in being able to put in place, the right clinical strategy for these very promising assets. So, thank you again. Look forward to updating you in the future. Andrea?
47:49 The conference is now concluded. Thank you for attending today's presentation, and you may now disconnect.